Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.
The Paragraph IV certification sought is with respect to applicable patents listed in the U.S. FDA’s Orange Book. Granules said it has also issued the requisite notice to the relevant parties in accordance with U.S. regulatory requirements.
India's Granules India has submitted a Paragraph IV certification to the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) of the cancer drug Ruxolitinib Extended-Release Tablets. The company anticipates first-to-file status for the drug, which would grant it 180 days of exclusivity in the U.S. market, according to a statement released on September 7, 2026.
This exclusivity opportunity is contingent on the FDA's approval and adherence to all relevant laws and regulations. Granules India has also notified the appropriate parties as required by U.S. regulations. The company's Chief Manufacturing Director, Krishna Prasad Chigurupati, highlighted the significance of first-to-file opportunities in their strategy to develop a more distinctive and valuable product portfolio in the U.S. market.
Ruxolitinib, a JAK1/JAK2 inhibitor, was granted FDA approval in 2011 and is primarily used for treating specific cancers and related conditions. Incyte Corporation, the U.S. developer and marketer of the drug under the brand name Jakafi, holds the exclusive rights. In May, Incyte announced the FDA's approval of Jakafi XR, the extended-release formulation of ruxolitinib, which is marketed in the U.S. by Incyte and internationally by Novartis under the brand name Jakavi.
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